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    Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature managemen unit. Not Sterile. Do not use if primary packaging has been previously opened or is damaged. Arizant Healthcare Inc., 10393 West 70th Street, Eden Prairie, MN 55344 USA.

    FDA Recall
    Terminated ·Arizant Inc·Product code DWJ·March 11, 2005

    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

    FDA Enforcement
    Class II ·Terminated·Sekisui Diagnostics P.E.I. Inc.·March 23, 2016

    CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10¿ in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeter. The provider can correct the patient position for simulation and treatments by tilting the device.

    FDA Enforcement
    Class II ·Terminated·Med Tec Inc·June 26, 2019

    AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 6, 2013

    Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·May 2, 2018

    MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc dba Bayer R&I·June 3, 2015

    CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10 in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeter. The provider can correct the patient position for simulation and treatments by tilting the device.

    FDA Recall
    Terminated ·Med Tec Inc·Product code IYE·April 15, 2019

    enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·May 4, 2016

    Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw System Tray #2; lT-CT1001Counter Torque (w/Large Rubber Handle); IT-HP1001 Head Positioner (w/Rubber Handle); IT-RP1001Rod Pusher; lT-RK1001 Rocker (Goal Post Style Tip); lT-BA1002 Vampire Awl; IT-RG1001 Rod Gripper, Ratcheting (Long Nose); IT-TP1001Tap, 4mm (Thin Style, Gold Tip); IT-TP1002 Tap, 5mm (Thin Style, Gold Tip) IT-TP1003 Tap, 6mm (Thin Style, Gold Tip); IT-TP1004 Tap, 7mm (Thin Style, Gold Tip); IT-SD 1002 Multiaxial Screwdriver (No Windows); IT-SD1005 Screwdriver Shaft 75 (w/BaIl Bearing); IT-CT1002 Counter Torque (Short No Windows); IT-SD1006 Multiaxial Screwdriver (w/Windows); IT-TP1005 Tap, 4mm (Silver Tn-Fluted); IT-TP1006 Tap, 5mm (Silver Tn-Fluted); IT-TP1007 Tap, 6mm (Silver Tn-Fluted); IT-TP1008 Tap, 7mm (Silver Tn-Fluted); lT-HP1002 Head Positioner (All Metal Handle); IT-RK1002 Rocker (Horse Shoe Style Tip); IT-SD1007 Screwdriver Shaft 8.5 (w/Ball Bearing); IT-CT1003 Counter Torque (Short w/Windows); IT-TP1014 Tap, 4mm (Silver Circumferential); IT-TP1015 Tap, 5mm (Silver Circumferential); IT-TP1016 Tap, 6mm (Silver Circumferential); IT-TP1017 Tap, 7mm (Silver Circumferential); IT-SD1007 Screwdriver Shaft 8.5 (No Ball Bearing); IT-XR1001 Extension Remover; IT-S01006 Screwdriver_Shaft 10 (No Ball Bearing); IT-FB1001 French Rod Bender; IT-SP1001 Ball Tip Probe; IT-TR1001 Trial Rod; IT-RG 1002 Rod Gripper, Ratcheting (Short Nose); IT-BP1003 Lumbar Probe, Straight (Long); IT-BP1004 Lumbar Probe, Curved (Long); IT-SP1002 Sounder (Ball Tip) Probe, Heavy Duty; RD-ST5540 Rod 5,5 x 400mm, Straight; IT-BA1001 Newport Awl; IT-PU 1001 Persuader; IT-RR1001 Retaining Ring; lT-NS1001 In-Situ Left; IT-N51002 In-Situ Right; IT-BP100S Lumbar Probe, Straight (Short); IT-BP1006 Lumbar Probe, Curved (Short); IT-CP1001 Compressor; IT-DT1001 Distractor; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; IT-RH1002 Ratcheting T-Handle; IT-NC1001 Locking Nut Caddy; IT-SG1001 Screw Gauge Block; IT-RH1002 Ratcheting Handle, Straight; IT-T01002 Preset Torque Wrench (With Connector); LG-LN1002 Locking Nut, Single Piece; LG-PR0530C Polyaxial Screw, Non-Winged, 5 X 30; LG-PR0535C Polyaxial Screw, Non-Winged, 5 X 35; LG-PR0540C Polyaxial Screw, Non-Winged, 5 X 40; LG-PR0545C Polyaxial Screw, Non-Winged, 5 X 45; LG-PR0550C Polyaxial Screw, Non-Winged, 5 X 50; LG-PR0630C Polyaxial Screw, Non-Winged, 6 X 30; LG-PR0635C Polyaxial Screw, Non-Winged, 6 X 35; LG-PR0640C Polyaxial Screw, Non-Winged, 6 X 40; LG-PR0645C Polyaxial Screw, Non-Winged, 6 X 45; LG-PR0650C Polyaxial Screw, Non-Winged, 6 X 50; LG-PR0730C Polyaxial Screw, Non-Winged, 7 X 30; LG-PR0735C Polyaxial Screw, Non-Winged, 7 X 35; LG-PR0740C Polyaxial Screw, Non-Winged, 7 X 40; LG-PR074SC Polyaxial Screw, Non-Winged, 7 X 45; LG-PR0750C Polyaxial Screw, Non-Winged, 7 X 50; LG-PR0755C Polyaxial Screw, Non-Winged, 7 X 55; LG-PR083SC Polyaxial Screw, Non-Winged, 8 X 35; LG-PR0840C Polyaxial Screw, Non-Winged, 8 X 40; LG-PR0845C Polyaxial Screw, Non-Winged, 8 X 45; LG-PR0850C Polyaxial Screw, Non-Winged, 8 X 50; LG-PR0855C Polyaxial Screw, Non-Winged, 8)( 55; LG-PW0535C Polyaxial Screw, Winged, S X 35; LG-PW0540C Polyaxial Screw, Winged, 5 X 40; LG-PW0545C Polyaxial Screw, Winged, 5 X 45; LG-PW0635C Polyaxial Screw, Winged, 6 X 35; LG-PW0640C Polyaxial Screw, Winged, 6 X 40; LG-PW0645C Polyaxial Screw, Winged, 6 X 45; LG-PW0735C Polyaxial Screw, Winged, 7 X 35; LG-PW0740C Polyaxial Screw, Winged, 7 X 40; LG-PW0745C Polyaxial Screw, Winged, 7 X 45; RD-PB5504 ROD 5.5 X 40, PRE-BENT; RD-PB5505 ROD 5.5 X 50, PRE-BENT; RD-PB5506 ROD 5.5 X 60, PRE-BENT; RD-PB5507 ROD 5.5 X 70, PRE-BENT; RD-PB5508 ROD 5.5 X 80, PRE-BENT; RD-PB5509 ROD 5.5 X 90, PRE-BENT; RD-PB5510 ROD 5.5 X 100, PRE-BENT; RD-PB5511 ROD 5.5 X 110, PRE-BENT; RD-PB5

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code NKB·August 21, 2008

    Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·October 3, 2012